MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UHR BIPOLAR 22X41MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Catalog Number	UH1-41-22
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the sales rep that right bipolar surgery done on (b)(6) 2024.Surgeon listed a revision bipolar (pji hip in eot) periprosthetic joint hip infection.Yes replacement was done with new bipolar cup and femoral head.Note: pji means periprosthetic joint infection.This case was scheduled in emergency operating theatre to do a revision bipolar.
Additional Manufacturer Narrative
The following devices were also listed in this report: 22.2mm std lfit v40 head; cat # 6260-9-122; lot# 20707658 it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

• Brand Name: UHR BIPOLAR 22X41MM
• Common Device Name: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: alessandra chavez ; 3365 enterprise ave; weston, FL 33331 ; 9546280700
• MDR Report Key: 20799273
• Report Number: 0002249697-2024-01646
• Device Sequence Number: 7809329
• Product Code: KWL
• UDI-Device Identifier: 07613327016819
• UDI-Public: 07613327016819
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K233498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: UH1-41-22
• Device Lot Number: PL4L5M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2024
• Initial Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/10/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female